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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Medical Epic II Critical Care Bed with Zoom Drive System; Model 2040.

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 Class 2 Device Recall Stryker Medical Epic II Critical Care Bed with Zoom Drive System; Model 2040.see related information
Date Initiated by FirmFebruary 01, 2008
Date PostedSeptember 19, 2008
Recall Status1 Terminated 3 on November 05, 2010
Recall NumberZ-1687-2008
Recall Event ID 45908
Product Classification hospital bed - Product Code FNL
ProductStryker Medical Epic II Critical Care Bed with Zoom Drive System, 115 V, Stryker Medical, Portage, MI.; Model 2040.
Code Information Serial numbers 0409060516 through 0711096116.
Recalling Firm/
Manufacturer
Stryker Medical Div. of Stryker Corporation
3800 E. Centre Ave.
Portage MI 49002
For Additional Information Contact
269-324-6609
Manufacturer Reason
for Recall
The brakes may not have adequate holding power to lock the bed in place.
FDA Determined
Cause 2
Device Design
ActionConsignees were notified via letter dated 2/1/08 and informed that upgrade kits along with full written and video installation instructions will be sent to correct the problem.
Quantity in Commerce66,558 of all models.
DistributionWorldwide, Argentina, Brazil, Canada, Chile, China, Greece, India Japan, Mexico, Poland, Singapore, South Africa, South Korea, Switzerland, Taiwan and United Kingdom.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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